NCT03505853已完成1 期
A Drug-Drug Interaction Study to Investigate the Effect of Givosiran on the Pharmacokinetics (PK) of Midazolam, Caffeine, Losartan, Omeprazole, and Dextromethorphan in Patients With Acute Intermittent Porphyria (AIP) Who Are Asymptomatic High Excreters (ASHE)
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年4月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail
研究概览
简要总结
The purpose of this study is to evaluate the effect of givosiran on the pharmacokinetics of the 5-probe cocktail of midazolam, caffeine, losartan, omeprazole, and dextromethorphan, and their metabolites, in asymptomatic patients with Acute Intermittent Porphyria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old
- •Weight between 45kg and 110kg, inclusive, if male
- •Weight between 45kg and 100 kg, inclusive, if female
- •Diagnosis of acute intermittent porphyria (AIP)
- •Elevated urine PBG level
- •Not be pregnant or breast feeding, and must be willing to use a highly effective method of contraception
排除标准
- •Clinically significant abnormal laboratory results
- •Experienced an acute porphyria attack within past 12 months
- •History of multiple drug allergies, intolerances or sensitivities
- •History of recurrent pancreatitis
- •Received an experimental drug, within 3 months of dosing
- •Donated or lost an excessive amount of blood within 60 days of dosing
研究组 & 干预措施
Givosiran with 5-probe cocktail
Experimental
干预措施: Givosiran (Drug)
Givosiran with 5-probe cocktail
Experimental
干预措施: 5-probe cocktail (Drug)
结局指标
主要结局
Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail
时间窗: Days 1 and 36
Maximum plasma concentration (Cmax)
次要结局
- Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail metabolites(Days 1 and 36)
- Safety as evaluated by the proportion of subjects experiencing adverse events (AEs)(Day 1 - Day 92)
- Profile of Pharmacokinetics (PK) of Cytochrome P450 (CYP) probe cocktail(Days 1 and 36)
- The pharmacodynamic (PD) effect of givosiran on urine levels of delta-aminolevulinic acid (ALA)(Days 1, 8, and 36)
- The pharmacodynamic (PD) effect of givosiran on urine levels of Porphobilinogen (PBG) in patients with AIP(Days 1, 8, and 36)
研究者
研究点 (1)
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